Survey Study - Sensitivity Comparison Between MelaFind and Physician Group

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MELA Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01011153
First received: November 10, 2009
Last updated: February 10, 2012
Last verified: February 2012

November 10, 2009
February 10, 2012
October 2009
February 2010   (final data collection date for primary outcome measure)
Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists) [ Time Frame: April 2010 ] [ Designated as safety issue: No ]
Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of all dermatologists to that of MelaFind. These metrics, for both the dermatologists and MelaFind, were calculated based on the same 130 lesions.
Comparison of biopsy/referral sensitivity and specificity of MelaFind and dermatologists (pigmented skin lesion experts and general dermatologists) [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01011153 on ClinicalTrials.gov Archive Site
  • Comparison of Biopsy/Referral Sensitivity and Specificity of MelaFind to the Average of Biopsy/Referral Sensitivity & Specificity in Each of the Three Groups of Physicians: Pigmented Skin Lesion Experts, General Dermatologists, and Primary Care Physicians [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
    Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of each group of physicians to that of Melafind, which is presented in the statistical analysis.
  • Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
    Each physician was given up to 130 cases and asked whether or not they would biopsy the lesion. Interobserver variability was measured via the kappa statistic indicating how well the physicians' answers to that question agreed within each group. Kappa statistics are reported in the statistical analysis. while numbers rep, they dont reflect the sgreement among the subjects
  • To Compare Biopsy/Referral Performance and Diagnostic Performance Using Areas Under the Corresponding Receiver Operating Characteristic (ROC) Curves That Illustrate the Trade-offs Between Sensitivity and Specificity Between Three Groups of Physicians. [ Time Frame: June 2010 ] [ Designated as safety issue: No ]
    For each case reviewed, physicians were asked if they thought the lesion was a melanoma (diagnostic sensitivity/specificity) and whether or not they would biopsy or refer the lesion (biopsy/referral sensitivity/specificity. These measurements were compared using areas under the corresponding receiver operating characteristic curves. (see statistical analysis for results) ROC curves (reciver operating curves) are plotted on graphs with an x-axis of sensitivity and a y-axis of 1-specificity.
  • Determine the interobserver variability in each of the above metrics within each of the caregiver groups. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
  • Comparison of biopsy/referral sensitivity and specificity of MelaFind and each of the three groups of physicians (pigmented skin lesion experts, general dermatologists, and primary care physicians) [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
  • Comparison of biopsy/referral accuracy and diagnostic accuracy using areas under the corresponding receiver operator characteristic (ROC) curve between three groups of physicians. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
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Survey Study - Sensitivity Comparison Between MelaFind and Physician Group
Comparison of Diagnostic and Biopsy/Referral Sensitivity to Melanoma Between Three Groups of Physicians and MelaFind

This survey study purposes to determine and compare the biopsy/referral sensitivity and specificity of MelaFind to the average biopsy/referral sensitivity and specificity of dermatologists. 241 subjects logged into system but only 183 signed consents and completed the intake survey. Out of these 183, 155 were accounted for in the data analysis after exclusions were removed from the pool of subjects.

Early detection of melanoma is critical for favorable prognosis, since patients with earlier stage melanomas have a much higher probability of survival than with later stages. The traditional method of early detection has been with serial total body skin exams where the health care provider examines all skin surfaces, including mucosa, for suspicious pigmented lesions. Studies have demonstrated that the diagnostic accuracy of physicians for melanoma depends on the level of dermatological training. More important than being able to make a diagnosis of melanoma on clinical impression is the ability to make an appropriate decision to biopsy the lesion. Primary care physicians (PCPs) are often expected to screen for melanoma and only refer to dermatologists when there is a high clinical suspicion of melanoma. However, if PCPs are not adept at diagnosing melanoma, then opportunities for early diagnosis and treatment could be missed. Conversely, the morphology of benign pigmented lesions can often mimic that of early melanomas, resulting in potentially unnecessary dermatology referrals, biopsies, and patient anxiety. Studies have indicated that there is great variability in the ability of PCPs to make a correct decision to biopsy/refer a pigmented lesion (1.5 times greater than dermatologists) as well as for diagnosing melanoma (over 2.5 times greater than dermatologists). To aid in detection of early melanomas, new technologies are being developed.

One such technology is MelaFind, an investigational device that has been developed to give a recommendation for biopsy (or not) of pigmented skin lesions to rule out melanoma. Our hypothesis is that MelaFind will have equal or better sensitivity than pigmented lesion experts in making an appropriate recommendation for biopsy (i.e., MelaFind will be at least as accurate as dermatologists in recommending biopsy for melanomas).

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

Three groups of health care providers who commonly encounter the skin will participate in the study. The population will comprise ninety physicians of which thirty are pigmented skin lesions experts, thirty general dermatologists and thirty primary care physicians.

Melanoma
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All Dermatologists
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Board Certified physicians or equivalent

Exclusion Criteria:

  • Did not participate in EOS Protocols 20061 or 20081
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01011153
20063
No
MELA Sciences, Inc.
MELA Sciences, Inc.
Not Provided
Principal Investigator: Suephy Chen, MD Emory University
MELA Sciences, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP